CompletedPhase 3Relapsing MSNCT01939002

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population <0.0001

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population

during the first 8 weeks of treatment

GroupValueIntervalNumber analysed
Overall Population10.3 percentage of participants194

p = <0.0001

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
BIIB017 Plus Current FLS Therapy1034 (3.9%)
BIIB017 Plus Naproxen986 (6.1%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population

    during the first 8 weeks of treatment

    FatigueSafety

Other measures (30)

  • Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms

    during the first 8 weeks of treatment

    Fatigue
  • Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment

    4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment

    Fatigue
  • Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks

    4-week run-in period, first 8 weeks of treatment

    Fatigue
  • Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks

    4-week run-in period, 48 weeks of treatment

    Fatigue
  • Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms

    4-week run-in period, first 8 weeks of treatment

    Fatigue
  • Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms

    4-week run-in period, 48 weeks of treatment

    Fatigue
  • Summary of Average Duration of FLS in the First 8 Weeks of Treatment

    4-week run-in period, first 8 weeks of treatment

    Fatigue
  • Summary of Average Duration of FLS in the 48 Weeks of Treatment

    4-week run-in period, 48 weeks of treatment

    Fatigue
  • Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment

    4-week run-in period, first 8 weeks of treatment

  • Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment

    4-week run-in period, first 8 weeks of treatment

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 65

Key Inclusion Criteria: * Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 [Polman 2005] * Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0 * Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening * All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. Key Exclusion Criteria: * Primary progressive, secondary progressive, or progressive relapsing MS [Lublin and Reingold 1996]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement * History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to IFN β-1a or polyethylene glycol * History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured) * History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline * Known allergy to any component of the BIIB017 formulation * An MS relapse that has occurred within the 50 days prior to Baseline (Day 1) and/or lack of stabilization from a previous relapse prior to Baseline. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017). Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.

Papers

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    Linked trials

    • Referred to by

      POP

      Completed

    Links found where a registry record names another trial's registry number.

    Related trials

    History

      1. Started

        Nov 2013

      2. Main results due

        Oct 2015

      3. Finished

        Nov 2015

      4. Results posted

        Jan 2017

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